US FDA’s Precision Medicine Efforts Turn Towards Adverse Events
Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.
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Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.
At White House summit on precision medicine, President Obama emphasized the need to break down outmoded regulations, and suggested barriers between drug and device oversight need to be loosened; FDA and NIH announced a number of new competitions and projects.
Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.